Trial Outcomes & Findings for Study of Apremilast in Atopic or Contact Dermatitis (NCT NCT00931242)
NCT ID: NCT00931242
Last Updated: 2010-12-20
Results Overview
Improvement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
12 weeks
Results posted on
2010-12-20
Participant Flow
Participant milestones
| Measure |
Apremilast
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
|
Screen Failures
Patients who were screened but failed to meet inclusion criteria for the study
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
2
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Apremilast in Atopic or Contact Dermatitis
Baseline characteristics by cohort
| Measure |
Apremilast
n=10 Participants
Apremilast is being evaluated at daily doses of 20 mg PO (by mouth) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type atopic dermatitis or allergic contact dermatitis.
|
Screen Failures
n=2 Participants
Subjects that were screened but failed to meet inclusion criteria for the study.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age Continuous
|
43.3 years
STANDARD_DEVIATION 14.2442971 • n=93 Participants
|
53.4 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
45 years
STANDARD_DEVIATION 13.0384048 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
2 participants
n=4 Participants
|
12 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksImprovement in IGA (Investigator Global Assessment) by two or more points on a five point scale, with 0 being no disease activity and 5 being maximum disease activity, at week 12
Outcome measures
| Measure |
Apremilast
n=10 Participants
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
|
|---|---|
|
Number of Patients Achieving an Improvement (Decrease) in IGA (Investigator Global Assessment) by Two or More Points
|
2 participants
|
SECONDARY outcome
Timeframe: 12 weeksEASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Outcome measures
| Measure |
Apremilast
n=10 Participants
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
|
|---|---|
|
Number of Patients Achieving 75% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0
|
1 participants
|
SECONDARY outcome
Timeframe: 12 weeksEASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, edema, lichenification, and excoriations/erosions are scored on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 to 6. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Outcome measures
| Measure |
Apremilast
n=10 Participants
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
|
|---|---|
|
Number of Patients Achieving 50% Reduction in Eczema Area and Severity Index (EASI) Score at Week 12 in Reference to Week 0
|
2 participants
|
Adverse Events
Apremilast
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Apremilast
n=12 participants at risk
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
|
|---|---|
|
Infections and infestations
Sepsis 2nd to Atopic Dermatitis
|
8.3%
1/12 • Number of events 1 • 10 months
|
Other adverse events
| Measure |
Apremilast
n=12 participants at risk
Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
|
|---|---|
|
Eye disorders
Conjunctivitis
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 2 • 10 months
|
|
Skin and subcutaneous tissue disorders
Burn
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 2 • 10 months
|
|
Cardiac disorders
asymptomatic sinus arrythmia per EKG
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
GI upset
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
soft stool
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
dermatitis flare
|
33.3%
4/12 • Number of events 4 • 10 months
|
|
Musculoskeletal and connective tissue disorders
foot fracture after mechanical fall
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Nervous system disorders
rigors
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Nervous system disorders
insomnia
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
seborrheic dermatitis
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
facial irritation from ketoconazole
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Eye disorders
ectropion
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
flatulence
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Infections and infestations
upper respiratory infection
|
16.7%
2/12 • Number of events 2 • 10 months
|
|
Eye disorders
atopic blepharoconjunctivitis
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Eye disorders
meibomian gland dysfunction
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Nervous system disorders
myalgias
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Nervous system disorders
chills
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Musculoskeletal and connective tissue disorders
lower back pain 2nd to motor vehicle accident (minor)
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Blood and lymphatic system disorders
b12 deficiency
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
increase in number of stools
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
hair dye allergy
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
diverticulosis
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
internal hemorrhoids
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
scraped shin from mechanical injury
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
nodules in breasts
|
8.3%
1/12 • Number of events 1 • 10 months
|
|
Skin and subcutaneous tissue disorders
MSSA skin infection
|
8.3%
1/12 • Number of events 1 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place